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Mycobacti-Loops

FDA UDI

Class I (US FDA UDI)

by Remel, Inc.

Identity

Trade Name
Mycobacti-Loops FDA UDI
Generic Name
Culture medium control FDA UDI
Device Name
M. intracellulare ATCC 13950 PK/1 FDA UDI
Model / Reference
R4610010 FDA UDI
Description
M. intracellulare ATCC 13950 PK/1 FDA UDI

Identifiers

Catalog Number
R4610010 FDA UDI
Primary DI / UDI-DI
00848838071690 FDA UDI
FDA Product Code
JTR FDA UDI
GMDN Term
Culture medium control FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.2480 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Culture medium control

Mycobacti-Loops by Remel, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Culture medium control.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Remel, Inc.

Sources (1)

  • FDA UDI a09edf22-52e5-4256-b119-a99f13e31865 34 fields · synced May 30, 2026